Supply and Distribution of FDA-Regulated Products

Written by an expert on FDA law and veteran litigator, Supply and Distribution of FDA-Regulated Products provides a detailed overview and analysis of the implementation of the most sweeping legislation in decades for FDA-regulated industries. Globalization of the marketplace and the events of September 11, 2001 have changed how Congress, government regulators, and industry view the movement of FDA-regulated products. Under the Drug Supply Chain Security Act and the Food Safety Modernization Act, Congress has rewritten the charge for the FDA to not only ensure that safe and efficacious products are marketed and respond quickly to outbreaks and adverse health outcomes, but also to anticipate and prevent these events before they occur.